The following data is part of a premarket notification filed by Tosoh Corp. with the FDA for Aia-pack Iri.
| Device ID | K903628 |
| 510k Number | K903628 |
| Device Name: | AIA-PACK IRI |
| Classification | Radioimmunoassay, Immunoreactive Insulin |
| Applicant | TOSOH CORP. COLUMBIA SQUARE 555 THIRTEENTH STREET, NW Washington, DC 20004 |
| Contact | Howard M Holstein |
| Correspondent | Howard M Holstein TOSOH CORP. COLUMBIA SQUARE 555 THIRTEENTH STREET, NW Washington, DC 20004 |
| Product Code | CFP |
| CFR Regulation Number | 862.1405 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-10 |
| Decision Date | 1990-09-07 |